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REACH绿色合规----豁免:物质已经注册 (REACH第7.6条)
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-30 | 330 次浏览 | 分享到:

如果您希望依赖已经对您的用途进行注册的物质的豁免,则您的供应链中行为人不需要进行注册,任何该候选物质的制造商或进口商注册即可。对于欧洲经济区内生产的物品或进口到欧洲经济区的物品,需要确认受注册支持的该物品中物质的用途以避免通报义务。 

如果满足以下两个条件,则认为物质的特殊用途已经被注册: 

• 相关的物质与已注册物质相同; 

• 相关的用途与已注册的物质用途之一相同。 

If you wish to rely on the exemption for a substance  that has already been registered for your use, the  registration does not need to have been done by an  actor of your supply chain, but could have been made  by any other manufacturer or importer of the CL  substance. For articles produced in or imported into  the EEA, it is necessary to confirm that the use of the  substance in the article is supported by the registration  in order to avoid the notification obligation.

A substance is considered to have already been  registered for a particular use, if two conditions are  fulfilled:

• The substance in question is the same as a substance that has already been registered; and, • The use in question is the same as one of the uses  described in a registration of this substance that was  already made.


第一步:检查物质的相同性此流程的第一步是确保相关的物质与某注册物质相同。对比两种物质的名称和EINECS 编号或CAS编号不足以确保两种物质相同 (见第5章,ECHA的“REACH和CLP规定 的物质标识与命名指南”中的“物质相同性检查标准”,https://echa.europa.eu/ documents/10162/23036412/substance_ id_en.pdf). 

Step 1: Check sameness of substance identity The first step in the process is to ensure that the  substance in question is the same as a substance  that has already been registered. Comparing names  and EINECS or CAS numbers of both substances may  not always be sufficient (see Chapter 5, “Criteria  for checking if substances are the same”, in ECHA’s “Guidance for identification and naming of substances under REACH and CLP”, https://echa.europa.eu/ documents/10162/23036412/substance_id_en.pdf).


第二步:检查注册用途的相同性物品中物质的潜在通报者必须检查其物品中物质的用途是否与本物质已注册的描述用途之一相同。为此,通报者必须描述其物品中物质的功能。通常某物质的功能会包含动词如“ 软化”(对于邻苯二甲酸酯(增塑剂)),但 由于注册卷宗和发布数据中不包含此类动词, 因此需要根据名词如“增塑剂”得出结论。此 外,还应描述物质加入物品中的工艺和物质加入物品的种类。 在确定物质是否适用于第7(6)条规定的豁免时,仅根据用途描述符系统对物质用途与用途描述进行比较不足以得出两种用途相同的结论。因此,“成品类别”(通常是只针对材料的宽泛描述)是不够详细的(参见ECHA的“物品中物质要求指南” https://echa.europa. eu/documents/10162/23036412/articles_ en.pdf)。所以,必须更为详尽地描述物质的用途,而非仅使用用途描述符系统的元素。

Step 2: Check sameness of registered uses A potential notifier of a substance in articles must  check if the use of the substance in his articles is the  same as one of the uses described in a registration  of this substance that was already made. For this he  has to describe the function of the substance in the  article. Normally the function of a substance would  include a verb e.g. ‘soften’ (in the case of a phthalate  (plasticiser)) but as the registration dossiers and the  dissemination data do not include this, it is necessary  to draw a conclusion from the noun e.g. plasticiser.  The process by which the substance is included in the  articles, and into which type of article, should also be  described. Comparing your use with a description of use based only  on the use descriptor system will not be sufficient to  conclude on the sameness of two uses for the purpose  of establishing whether an exemption on the basis  of Art. 7.6 applies. Thus, the “article category” (which  is generally a very broad description often referring  only to the material) will not be detailed enough (see  Chapter 3.3.1 of ECHA’s“Guidance on requirements  for substances in articles” https://echa.europa. eu/documents/10162/23036412/articles_en.pdf).  Therefore, the use in question has to be described in  more detail than just by using elements of the use  descriptor system.


物质已公开发布的在“塑料物品”物品类别中注册用途的信息不意味着本注册涵盖所有的塑料物品。本信息表示注册涵盖并描述了物质在某些特定塑料物品生产中的用途,而并未涵盖和评估其他塑料物品。使用两种差别很大的塑料物品可能会导致明显不同的人体和环境暴露。如果与物品用途相关的暴露未在注册卷宗中给予充分评估,其不能被视为已注册用途。 

The published information that a substance has been  registered for use in the Article Category “Plastic  articles” does not necessarily mean the registration is  made to cover all plastic articles. It could mean that use  of the substance in production of some specific plastic  articles is covered and described in the registration,  while other plastic articles are not covered and  assessed. The uses of two very different plastic articles  may lead to very different exposures to humans and  the environment. If the exposure related to the use of  your article is not adequately assessed in a registration  dossier, it cannot be considered a registered use.


因此,强烈建议联系相应机构,如:物质信息交换论坛、领头注册人、物质联合体及物质主管协会,利用其他注册用途的信息来源。另见第5.9.1节以参考相关汽车行业物质通报情况说明书。由于商业机密性考虑可能会阻碍所需信息的披露,因此在实践中努力与这些机构进行联系可能会很困难。建议对这些通信进行记录。 

It is therefore strongly recommended to use other  information sources on registered uses by contacting  appropriate bodies, such as SIEFs, lead registrants, substance consortia and substance-responsible associations. See also Chapter 5.9.1 for reference to the relevant automotive industry substance notification factsheets. Efforts to make contact with these bodies  can prove to be difficult in practice as business  confidentiality considerations may thwart the disclosure  of the required information. It is recommended that any  such correspondence is recorded.


如果您有生产或进口物品清单,则可能拥有关于材料及生产量/进口量的信息。一旦物质被纳入候选清单(参见第5.3节),此类信息将为你是否需要进行通报提供第一手指示。

If you have an inventory for the articles that you  produce or import, you may have information about  the materials and the produced/imported volumes.  This information will provide you with a first indication  on whether a notification may be required once a  substance is included in the CL (see chapter 5.3).


示例 

关于如何使用电线和电缆中DEHP的案例来检查您使用的候选清单物质在已完成注册内: 

Example

on how to check that your use of a CL substance is  covered by an already made registration using the  case of DEHP in electric wires and cable:

1.检查DEHP是否已被注册

a)通过以下链接访问欧洲化学品管理局网站: https://echa.europa.eu/informationon-chemicals/registered-substances 

b)通过输入CAS号117-81-7检查DEHP的注册 状况; 结果:完整的注册卷宗数据可用 

1.Check whether DEHP has already been registered.

a) Go to the ECHA website by following the link: https://echa.europa.eu/information-on-chemicals/ registered-substances

b) Check registration status for DEHP by entering the  CAS number 117-81-7. RESULT: full registration dossier data available


2.检查相关的物质是否与已注册的物质相同, 至少通过比较两种物质的名称和EINECS编号或CAS编号。 

2. Check that the substance in question is the same  as the substance that has already been registered,  at least by comparing names and EINECS or CAS  numbers of both substances.


3.检查物品类别是否已包含在注册卷宗中。在本示例中,你必须检查“电线和电缆”,还应包括其近义词,如:绝缘套管、线束、电缆组件、接线总成等。欧洲化学品管理局网站公布的注册物质清单中不包含此信息,必须通过其他途径才能获得,例如:从领头注 册人、联盟、协会、互联网等。在收到上述其他来源的所需信息后,对“电线和电缆” 进行检查。如果信息中包含你的物品类别, 则表明你的成品已注册。 

3. Check if the type of article is covered in the registration  dossier. In this example you must check for “electric  wires and cable”, covering also its synonyms, e.g. wiring loom, wiring harness, cable assembly, wiring  assembly, etc. This information is not available on the registered substance list disseminated on  the ECHA website and must be obtained by other  means, e.g. from the lead registrant, consortium,  association, internet etc. After receiving requested  information from the above mentioned additional  sources, check for “electric wires and cable”. If this  covers your article category you are covered by the  already made registration.


假设一个用于汽车的PVC电缆中含DEPH: 

在这种情况下,DEHP的最终用途不是已安装“PVC电缆”物品的车辆(物品类别1), 而是物质本身的最终用途,即加入到PVC电缆中。因此,物品类别可能是橡胶品(AC 10) 或塑料品(AC 13)。 

Suppose a PVC cable containing DEHP is used in a vehicle:

In this case the end use of DEHP is not the vehicle  (AC 1) to which the article“PVC Cable”has been attached. Instead it is the end use of the substance  itself, which is the inclusion into the PVC cable. Therefore the AC might be e.g. rubber articles (AC 10) or plastic articles (AC 13).


1.检查电线和电缆的用途部分。DEHP的注册卷宗规定“消费者使用:日用品(=广大公众=消费者)”如果此涵盖你的用途部分, 则表明你的物质用途被涵盖在已注册范围内。

2.检查注册卷宗中的产品类别。对于电线和电缆,产品类别为“聚合物配制品和混合物” 。如果此涵盖你的产品类别,则表明你的产品类别被涵盖在已注册范围内。

3.检查注册卷宗中的环境释放类别(ERC)。对于成品电线和电缆,其暴露类别为: 

• 成品和材料在室外使用的整个寿命周期内所含的低释放物质,例如:金属、木材和塑料结构及建筑材料(水槽、排水管、框 架等)(ERC10a) 

• 成品和材料在室外使用的整个寿命周期内所含的高释放或有意释放物质。例如:轮胎、已加工的木制品、百叶窗、阳伞和家具等已加工的纺织品、商用船舶和游艇所用的锌阳极、卡车或汽车的刹车片等。另外,还包括因工人处理导致的物品基体释放物质。这类工艺一般与PROC21、24 、25有关,例如:建筑物(桥梁、立面) 或车辆(船舶)的磨光。 (ERC11a) 

如果你的环境释放类别与卷宗描述相同,则表明你物质的环境释放类别被涵盖在已注册范围内。 

1.Check the sector of use (SU) of electric wires and cable. The registration dossier for DEHP specifies  “Consumer uses: Private households (=general public = consumers)”. If this covers your Sector of Use you  are covered by the already made registration, AND

2.Check the product category (PC) in the registration  dossier. For electric wires and cable the product  category is “Polymer preparations and compounds”.  If this covers your product category you are covered  by the already made registration, AND

3.Check the exposure release category (ERC) included  in the registration dossier. In the case of the articles  electric wires and cables, the exposure release  categories are: 

• “Low release of substances included into or onto  articles and materials during their service life in  outdoor use, such as metal, wooden and plastic construction and building materials (gutters,  drains, frames, etc.)” (ERC10a) 

• “Substances included into or onto articles and materials with high or intended release during their service life from outdoor use. Such as tyres, treated  wooden products, treated textile and fabric like sun  blinds and parasols and furniture, zinc anodes in  commercial shipping and pleasure craft, and brake  pads in trucks or cars. This also includes releases  from the article matrix as a result of processing by  workers. These are processes typically related to  PROC 21, 24, 25, for example: Sanding of buildings  (bridges, facades) or vehicles (ships)” (ERC11a)

If your exposure release category is the same, then  you are covered by the already made registration of  the substance.


4.确认DEHP在物品中的用途没有受到限制: 

a) 点击详细信息,转至“制造、使用与暴露” 章节,确认是不存在针对你的使用范围的禁用规定。 

b) 如果未列出适用的限制,则被涵盖在已注册范围内。 

注:使用未被注册,则采取措施如果发现你的物质用途未被注册,建议你采取必要措施,确保你的物质用途被涵盖在内。相关措施选项,请参见第5.5节“REACH 第V篇规定的下游用户的义务”。 

4. Confirm that there are no restrictions on use(s) of  DEHP in the article for your use:  

a) Click on details and go to chapter “Manufacture,  Use & Exposure” and confirm that no uses advised against your scope of use are listed. 

b) If no applicable restrictions are listed, you are covered by the already made registration.

NOTE:Action if use is not covered Should you find your use is not covered by an already  made registration, you are recommended to take  necessary action making sure your use is covered.  Please refer to Chapter 5.5 “Downstream User  Obligations according to REACH, Title V” for options.


5. 结论:如果你认为上述示例包含你的DEHP 在电线和电缆中的用途,则无需进行通报。 相关的结论和要素应进行仔细的记录,以便在需要时,可向主管机构证明自己的 REACH合规性。 

注:如果不确定您的使用是否已注册,请采取措施 

» 在物品中加入物质属于“使用”。但是,将含有特定物质的物品投放到市场不属于物质的使用。 

» 包装属于物品或由物品组成的复杂物件,因此若包装中的候选清单物质超过 0.1% w/w和1吨每年的限值,则需要进行通报。 

» 在您业务过程中可能分销的其他销售点或营销材料也被视为物品,因此需要再次考虑候选清单物质的存在。 如果您正在检查本章所述的用途注册, 但您仍不确定您的具体用途是否已经注册,则应考虑自己进行通报。 

5. Conclusion: If you consider that the example above  covers your uses of DEHP in electric wires and cable,  no notification is necessary. The conclusion obtained  and the considerations that led to it should be well  documented in order to be able to demonstrate REACH  compliance towards authorities when required.

NOTE:Action if not certain your use is registered 

» Incorporation of a substance in an article is a “use”. However, the placing on the market of an article containing a specified substance is not a  use of that substance. 

» Packaging is either an article or a complex object  made of articles, and so the presence of a CL substance in packaging may need to be notified if it  exceeds the 0.1% w/w limit and the 1 tpa threshold. 

» Other promotional point of sale or marketing materials you may distribute in the course of your  business are also considered as articles, and so  the presence of a CL substance again needs to be  considered. If you were checking the registration of the use as described in this chapter but you are still not certain that your specific use is already registered,  you should consider your own notification.


请参阅每种候选清单物质的通报情况说明书 (见第5.9.1节)

Please refer to the factsheet on notification for each  substance on the CL (see Chapter 5.9.1).



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